NCT00135967

Brief Summary

Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects. In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

December 6, 2005

Status Verified

August 1, 2005

First QC Date

August 25, 2005

Last Update Submit

December 5, 2005

Conditions

Glomerulonephritis, Membranous

Keywords

membranous nephropathymycophenolate mofetilcyclophosphamideprednisone

Outcome Measures

Primary Outcomes (2)

  • renal function (serum creatinine)

  • proteinuria

Secondary Outcomes (2)

  • side effects

  • relapse rate

Interventions

mycophenolate mofetil orally 1000 mg twice a day (BID)DRUG
prednisone 0,5 mg/kg orally on alternate daysDRUG
intravenous (i.v.) methylprednisolone 1000 mg, total 9DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Membranous nephropathy
  • Serum creatinine (Screat)\> 1,5 mg/dl or ECC \< 70 ml/min or increase Screat \> 50%
  • Proteinuria \> 2 g/day

You may not qualify if:

  • Systemic diseases
  • Pregnancy wish
  • Active infection
  • Liver dysfunction
  • Abnormal hematology lab
  • Unstable angina
  • Nonsteroidal anti-inflammatory agents (NSAIDs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.

    PMID: 17660026DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

BID protein, humanMethylprednisolone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jack F Wetzels, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

May 1, 2002

Last Updated

December 6, 2005

Record last verified: 2005-08

Locations

NL(1)